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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01732705
Other study ID # HIT-T2DM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2012
Est. completion date December 2014

Study information

Verified date February 2021
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of High Intensity Interval Training (HIT) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.


Description:

Physical exercise increases insulin sensitivity in skeletal muscle in healthy as well as in individuals with type 2 diabetes, but implies a considerable time commitment. High intensity interval training (HIT) is time-efficient exercise consisting of repeated bouts of short duration high intensive workloads. The aim of this study is to determine the effect of HIT in patients with type 2 diabetes, and to clarify the mechanisms of a possible positive effect of HIT. Exercise is performed as 2 weeks one-legged training on an ergometer bicycle. Thus one leg serves as a control leg. Insulin sensitivity in trained and non-trained muscle will be measured after completion of the overall training program by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs. Muscle biopsies will be obtained during training period for measuring of muscle glycogen content, and muscle biopsies for further analysis obtained during the experimental day.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: - 10 subjects with Type 2 diabetes. 10 healthy control subjects. - BMI 28-35 - diet or tablet treatment for diabetes Exclusion Criteria: - regular physical activity - diseases other than type 2 diabetes - insulin treatment

Study Design


Intervention

Behavioral:
High intensity interval training
HIT will be conducted as 2 weeks of one legged high intense interval training (8 sessions every 2nd day). Each training session will consist of 10 x 1 min intervals on ergometer bicycle interspersed with 1 min recovery.

Locations

Country Name City State
Denmark Xlab, Department of Biomedical Sciences, University of Copenhagen Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
University of Copenhagen The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Glycogen content in skeletal muscle Analysis of glycogen content from muscle biopsies taken during the training period. 17 days. Before and after training session day 1, 7 and 15. Before and immediately after isoglycemic, hyperinsulinemic clamp day 17.
Primary Insulin sensitivity Insulin sensitivity in trained and non-trained muscle will be measured by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs. 2 days after last training session (day 17)
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